Systemic lupus erythematosus (SLE)
Conditions
Interventions
Observation group:Qihuang Jianpi Zishen Granules+Prednisone+Hydroxychloroquinone Sulfate
Control group:Prednisone+Hydroxychloroquinone Sulfate
Sponsors
The First Affiliated Hospital of Anhui University of Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Compliant with the 2019 European League Against Rheumatism (EULAR) American College of Rheumatology (ACR, American College of Rheumatology); (2) Those with spleen and kidney deficiency syndrome in TCM syndrome; (3) Females with >=18 years and 0.5×10^9/L) or 30×10^9/L<PLT<100×10^9/L or 30g/L<HGB<110g/L, one or two or three lines damaged. (2) Subgroup 2: 0.5 g/d< proteinuria<=1.0g/d (urine protein+++) or renal biopsy pathology consistent with type I.-II lupus nephritis.
Exclusion criteria
Exclusion criteria: (1) Those who are allergic to the study drug; (2) Fundus and visual field lesions or arrhythmias; (3) Patients with other rheumatic immune diseases; (4) Severely infected people; (5) Coombs test (+); (6) Those who meet the enrollment criteria of subgroup 1 and subgroup 2 at the same time; (7) Subgroup 1 Hematologic Impairment Drugs; (8) Subgroup 2 patients with serum creatinine >185umo1/L; (9) Those who have used biological agents or immunosuppressants (except hydroxychloroquine sulfate) in the past 12 weeks; (10) Pregnant, lactating, and mentally ill patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SLE disease activity score;Hematology indicators;Immunological indicators;Renal damage indicators;Scoring of Traditional Chinese Medicine Symptoms and Signs;Quality of life assessment, Self Rating Depression Scale (SDS), and Self Rating Anxiety Scale (SAS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs (e.g., blood pressure, breathing, heart rate, pulse, etc.);Urine, stool routine, coagulation routine, electrocardiogram;Blood routine, liver and kidney function; | — |
Countries
China
Contacts
Public ContactMing Li
The First Affiliated Hospital of Anhui University of Chinese Medicine
Outcome results
None listed